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The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Yband(YDT-201N)

Sham-Yband(YDT-201N)

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
Greater than 22 points of Montgomery-Asberg Depression Rating Scale
Aged 19 to 65.
Has provided informed consent

Exclusion Criteria:

Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
History of suicidal attempt in the last 6 months
Diagnosed with bipolar or psychotic major depressive disorder
Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
Has hypersensitivity to sertraline ingredients
A score of 5 or greater for the question #10 in MADRS
Diagnosed with closed angle glaucoma or has a history of glaucoma.
History of participation in other clinical trials within 30days.
A major and/or unstable medical or neurologic illness
Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide
Pregnant or has a positive pregnancy serum test.

Sites / Locations

Ybrain

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

YBand(YDT-201N)

Sham-Yband(YDT-201N)

Arm Description

transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)

sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)

Outcomes

Primary Outcome Measures

Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.

Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

The percentage of subjects whose MADRS score is under 10 in week 6 after treatment.

Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)

Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)

Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)

Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Full Information

NCT ID

NCT02657980

First Posted

June 22, 2015

Last Updated

January 24, 2017

Sponsor

Ybrain Inc.

Collaborators

Severance Hospital, Gangnam Severance Hospital, Myongji Hospital, CHA University, National Health Insurance Service Ilsan Hospital, Ajou University, Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02657980

Brief Title

The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Official Title

The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ybrain Inc.

Collaborators

Severance Hospital, Gangnam Severance Hospital, Myongji Hospital, CHA University, National Health Insurance Service Ilsan Hospital, Ajou University, Hallym University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Detailed Description

Patients will be randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients will visit the hospital to get tDCS administrations 5 days a week for 2 weeks. They will be evaluated every 2 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Major Depressive Disorder, tDCS, MDD, transcranial Direct Current Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YBand(YDT-201N)

Arm Type

Experimental

Arm Description

transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)

Arm Title

Sham-Yband(YDT-201N)

Arm Type

Sham Comparator

Arm Description

sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)

Intervention Type

Device

Intervention Name(s)

Yband(YDT-201N)

Intervention Description

transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Intervention Type

Device

Intervention Name(s)

Sham-Yband(YDT-201N)

Intervention Description

transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Primary Outcome Measure Information:

Title

Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Description

Measured by Montgomery-Åsberg Depression Rating Scale (MADRS)

Time Frame

from baseline to Week 6

Secondary Outcome Measure Information:

Title

Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Description

The percentage of subjects whose MADRS score decreases over 50% against the base in week 6 after treatment.

Time Frame

At 6 weeks after treatment.

Title

Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

Description

The percentage of subjects whose MADRS score is under 10 in week 6 after treatment.

Time Frame

At 6 weeks after treatment

Title

Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)

Description

Average change of CGISI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Time Frame

At 2 weeks, 4 weeks and 6 weeks after treatment

Title

Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)

Description

Average change of K-BDI-II at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Time Frame

At 2 weeks, 4 weeks and 6 weeks after treatment

Title

Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)

Description

Average change of K-BAI at 2 weeks, 4 weeks and 6 weeks after treatment compare to the base respectively.

Time Frame

At 2 weeks, 4 weeks and 6 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features) Greater than 22 points of Montgomery-Asberg Depression Rating Scale Aged 19 to 65. Has provided informed consent Exclusion Criteria: Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.) History of suicidal attempt in the last 6 months Diagnosed with bipolar or psychotic major depressive disorder Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified. Has hypersensitivity to sertraline ingredients A score of 5 or greater for the question #10 in MADRS Diagnosed with closed angle glaucoma or has a history of glaucoma. History of participation in other clinical trials within 30days. A major and/or unstable medical or neurologic illness Currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide Pregnant or has a positive pregnancy serum test.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seungwoo Lee

Organizational Affiliation

Ybrain Company

Official's Role

Study Director

Facility Information:

Facility Name

Ybrain

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

The Effect of tDCS in Patients With Moderate to Severe Major Depressive Disorder

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